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Mother-Child RelationsNCT03271723

The 2015 Pelotas (Brazil) Birth Cohort Study

An observational study of Mother-Child Relations and Preterm Birth, run by Federal University of Pelotas at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is the fourth birth cohort to be carried out in the city of Pelotas (Brazil) including more than 4 thousand children followed-up since the pre-natal period to study maternal-child health. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Observational study
How many people
4,275 participants
Where
1 siteBrazil
Study dates
15 Apr 2014to 31 Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: All live births from mothers living in Pelotas during the year 2015 were included in the birth cohort to be followed-up since birth.

Who may be able to join

  • live births
  • mothers living in urban area of the city
  • delivered during 2015

Who cannot join

  • stillbirths below 500g
  • mothers living outside Pelotas

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Physical Education School

    Pelotas, Rio Grande do Sul, 96055-630

Other trials in Brazil

About this study

This is the fourth birth cohort to be carried out in the city of Pelotas (Brazil) including more than 4 thousand children followed-up since the pre-natal period to study maternal-child health.

Read the detailed description

The Pelotas 2015 Birth cohort is the fourth birth cohort being established in Pelotas since 1982. Data is being collected with a focus on maintaining fidelity to the tools and instruments used in the previous cohorts with minimal adaptations when necessary. All children born in Pelotas during 2015 were included in the cohort, and the cohort has been followed four times, at birth, 3, 12 and 24 months (ongoing). In addition, an antenatal study identified and interviewed 73.8% of the mothers that subsequently delivered children that are now part of the cohort. The 4275 children included in the cohort are part of extensive assessments that include information on antenatal health and care, pregnancy health, gestational age, physical activity, sleep, health behaviours, socio-demographic characteristics, perinatal conditions, child anthropometry, delivery information, child mortality and morbidity, nutrition, growth, breastfeeding, neuro-cognitive development, access to health services, medicine use by both mother and child and genetic material. The cohort also nests 2 randomized clinical trials and a series of sub-studies. The data is starting to be analyzed and, among other findings, confirm the already alarming trends in surgical deliveries, amounting to 65.2% of all deliveries in 2015.

Being tested
Observational study
Keywords
cohort studies, infant development, pregnancy, Brazil, observational studies, epidemiology, maternal health
Medical subject headings
Premature Birth, Breast Feeding, Motor Activity, Narrative Medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational studyOther

    No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preterm birth

    Births before 37 weeks of pregnancy

    Measured: At birth

Secondary outcomes (1)

  1. Physical activity

    Physical activities performed during pregnancy

    Measured: Second trimester of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2017
  2. Study start15 Apr 2014
  3. Primary completion31 Dec 2014
  4. Study completion31 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03271723
Sponsor's protocol ID
C2015
Status last verified
Aug 2017
First submitted
25 Aug 2017
Last updated
5 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Domingues MR, Bassani DG, da Silva SG, Coll Cde V, da Silva BG, Hallal PC. Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial. Trials. 2015 May 24;16:227. doi: 10.1186/s13063-015-0749-3.

    PubMed 26003406

  • Santos IS, Bassani DG, Matijasevich A, Halal CS, Del-Ponte B, da Cruz SH, Anselmi L, Albernaz E, Fernandes M, Tovo-Rodrigues L, Silveira MF, Hallal PC. Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial. BMC Psychiatry. 2016 Sep 2;16(1):307. doi: 10.1186/s12888-016-1016-1.

    PubMed 27590170

  • Coll CVN, da Silveira MF, Bassani DG, Netsi E, Wehrmeister FC, Barros FC, Stein A. Antenatal depressive symptoms among pregnant women: Evidence from a Southern Brazilian population-based cohort study. J Affect Disord. 2017 Feb;209:140-146. doi: 10.1016/j.jad.2016.11.031. Epub 2016 Nov 26.

    PubMed 27914247

  • Coll CV, Domingues MR, Hallal PC, da Silva IC, Bassani DG, Matijasevich A, Barros A, Santos IS, Bertoldi AD. Changes in leisure-time physical activity among Brazilian pregnant women: comparison between two birth cohort studies (2004 - 2015). BMC Public Health. 2017 Jan 25;17(1):119. doi: 10.1186/s12889-017-4036-y.

    PubMed 28122524

Questions about this trial

What is this clinical trial studying?

An observational study of Mother-Child Relations and Preterm Birth, run by Federal University of Pelotas at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preterm birth (time frame: At birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03271723, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.

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